The European Mobility Week is a campaign of the European Commission with the aim of improving the quality of life of citizens in urban areas by promoting alternative and innovative urban transport solutions. It is celebrated every year from September 16 to 22, and this year's theme was about saving fuel and energy in general and was carried out under the slogan "Let's move better - save energy!" The goal is to encourage citizens to walk, cycle and use alternative transport solutions affect the reduction of energy consumption, the reduction of environmental pollution, but also the improvement of living conditions and health.

 

We celebrated the EU mobility week on September 20 in cooperation with the City of Karlovac, the City Library "Ivan Goran Kovačić" Karlovac, the Traffic Police of the city of Karlovac, and Aquatika - Freshwater Aquarium Karlovac, which began with the closure of Radićeva Street from the rotor on Rakovac to the intersection with Elementary School Dragojla Jarnević from 8 a.m. to 12 p.m., by cycling the Cycle Librarian from the City Library I. G. Kovačić to Aquatika. Then an exhibition of children's works on the topic of mobility in traffic was viewed in Aquatica, and the thematic guidelines for 2023 were displayed at the info stand of Europe directa, i.e. quick guides with the theme "Let's save energy" which were distributed to everyone, after which a lecture was held for 4th grade students Braća Seljan Elementary School on traffic safety in cooperation with the Karlovac Traffic Police. In order to check how carefully they listened to the lecture, a quiz followed and the best three teams won valuable gifts provided by Europe direct Karlovac.

The European Mobility Week ends with the European Car Free Day, which is celebrated on September 22.

The climate changes we are witnessing, the need to save energy, the hectic pace of life and health care are our daily routine. Let's not just wait for the European Mobility Week to take part in the activities and think about how each of us can get involved and make small steps to reduce environmental pollution and improve living conditions and health.

 

„It is the moment to show to the young generation that we can build a continent where you can be who you are, love who you want, and aim as high as you want. A continent reconciled with nature and leading the way on new technologies. A continent that is united in freedom and peace. This is Europe’s moment to once again answer the call of history.“

Ursula von der Leyen, President of the European Commission

 

In her State of the Union address on 13 September 2023, President of the European Commission Ursula von der Leyen outlined the main priorities and flagship initiatives for the year to come, building on the European Union's successes and achievements of the past years.

Proposed initiatives

1. A European Green Deal

 

• • European Wind Power Package
• • 2040 climate target
• • Initiative for water resilience

 

 

A Europe fit for the digital age

 

• • EU Space Law
• • Strategy on Space Data Economy
• • Initiative to open up European supercomputer capacity to ethical and responsible AI start-ups start-up poduzećima u području umjetne inteligencije

 

 

An economy that works for people

• • EU Biotech and Biomanufacturing Initiative
• • Follow up to the Val Duchesse Summit
• • Advanced Materials for industrial leadership
• • Initiative on rules on the European Works Council

A stronger Europe in the world

• • Strengthen partnership with Africa
• • European Defence industrial strategy

 

 

Promoting our European way of life

• • Extension of Temporary Protection for people fleeing Ukraine
• • Action Plan on anti-drug trafficking, including European Ports Alliance
• • Action Plan on anti-drug trafficking, including European Ports Alliance
• Joint European degree

 

A new push for European democracy

• • Communication on pre-enlargement reforms and policy reviews
• • Commission Recommendation on integrated child protection systems

 

 

 

Letter of Intent

President von der Leyen also sent a Letter of Intent to Roberta Metsola, the President of the European Parliament, and Prime Minister Pedro Sánchez of Spain, which currently holds the Presidency of the Council. In it, she details the actions the Commission intends to take in the following year by means of legislation and other initiatives.

 

For more informations: https://state-of-the-union.ec.europa.eu/index_en

Today, on 08 September 2023, ahead of President von der Leyen’s State of the Union address on 13 September 2023, the Commission published an overview of the work and achievements of  the past year.

 

This comprehensive publication describes the EU’s actions in response to Russia’s war of aggression against Ukraine and our efforts to reduce the EU’s dependence on Russian fossil fuels, as well as progress on other political priorities of the Commission.

It outlines the actions taken by the Commission to strengthen the EU’s prosperity and resilience through NextGenerationEU and RePowerEU to accelerate the implementation of the European Green Deal and deliver on Europe’s Digital Decade.

It also provides an overview of the EU’s engagement with partners around the world, in particular the trade agenda, as well as initiatives taken to strengthen the pillars of European democracy and build a Union of Equality.

All updates on the 2023 State of the Union address are available on the dedicated SOTEU  website. -a.

Today, the Commission has selected 159 projects to be funded under the Erasmus+ “Capacity Building in Higher Education” actionHR, which supports the modernisation and quality of higher education in countries around the world. These projects will contribute to the overall objective of strengthening international cooperation in the field of higher education, improving education systems and enhancing growth and prosperity in the world.

Through projects selected this year, 2500 higher education stakeholders from almost 130 countries (including EU Member States) will work together to modernise and internationalise higher education. A total 2023 budget of EUR 115.3 million will be used, for example, for the professionalisation of mathematics teaching in Central Africa, university studies in equality and equality law for vulnerable groups in Latin America, study programmes for a sustainable blue economy in the Southern Mediterranean and programmes to foster profound changes in health education in Southeast Asia.

This year, the EU also committed an additional EUR 5 million to Ukraine to finance a large-scale project under the Erasmus+ programme. The DigiUni project, which will last four years, will create a digital platform for Ukrainian universities, which will particularly benefit students who have had to flee the country or have been internally displaced. It will allow students enrolled in Ukrainian higher education institutions to continue their education in Ukrainian language and according to the Ukrainian curriculum.

The Erasmus+ capacity building initiative in higher education is part of activities that foster student and staff exchanges and support cooperation in the field of education between Europe and the rest of the world.

More information is available here https://ec.europa.eu/commission/presscorner/detail/en/IP_23_4007..

Civil society organisations, individuals and private companies can now apply their non-profit projects for the EESC Prize to support the mental well-being of Europeans.

The European Economic and Social Committee (EESC) as launched its 14th Civil Society Prize.By choosing mental health as this year's theme, the EESC will reward creative and innovative non-profit projects that help individuals with mental health conditions and create a supportive environment for their mental well-being, whether on an individual level or as a collective effort.

will be awarded to a maximum of five winners. A total of EUR 50 000.

The deadline for entries is 10 a.m. (Brussels time) on 30 September 2023.

The award ceremony is likely to take place during the EESC Civil Society Week in spring 2024.

The aim of the EESC's flagship Civil Society Prize is to raise awareness of civil society's outstanding contribution to creating a European identity and citizenship and to promoting the common values that bolster European integration. Each year, the prize focuses on a different theme particularly relevant to the EU.

WHO CAN APPLY?

Applications can be submitted by all civil society organisations officially registered within the European Union and acting at local, regional, national or European level. The prize is also open to individuals who reside in the EU, as well as to companies registered or operating within the EU, provided that their projects are strictly not-for-profit.

All eligible initiatives and projects have to be carried out in the EU. They must have already been implemented or still be ongoing. Those which are planned but which have not begun implementation by 30 September 2023 will be excluded.

The full description of requirements and the online application form are available on our webpage..

WHICH PROJECT THEMES ARE ELIGIBLE?

To be eligible, the entries must cover at least one of the issues listed in the eligibility criteria published in the Rules governing the 14th EESC Civil Society Prizeavailable on the EESC's dedicated webpage. web page.

Among other things, projects can focus on preventing and combating psychosocial risks at work and promoting supportive workplace cultures, reaching out to people at risk of mental health problems, providing crisis intervention and ensuring person-centred services for mental health.

They can also address the mental health needs of disadvantaged groups and ageing populations or promote mental well-being in children and adolescents, by tackling issues such as substance use and abuse, cyberaddiction, youth violence and bullying.

Projects focused on community work such as empowering local communities, creating networks for community involvement and establishing a supportive environment for mental health will also be eligible. Improving mental health literacy and combating the stigma which often deters people from seeking help are also acceptable as entry themes.

The EESC hopes its prize will honour and showcase the non-state efforts made so far to help people battling with mental health issues. It also aims to encourage ongoing projects and inspire new ones, thus highlighting the contribution such projects can make to curbing the explosion of this silent epidemic in the EU.

To apply, click  here..

MORE ABOUT THE THEME OF THIS YEAR'S PRIZE

During and in the aftermath of the COVID-19 pandemic, Europe saw an unprecedented spike in mental health conditions and disorders. Anxiety and depression were particularly prevalent among the elderly and vulnerable groups, and most of all among young people, with figures showing that the rate of depressive symptoms more than doubled among those aged 18 to 29 in several European countries.

The heavy impact of mental health issues on the EU population, with roughly 4% of annual deaths attributed to mental health and behavioural disorders and the direct and indirect costs of mental health problems accounting for almost 4% of GDP, pushed mental health to the top of the EU's political agenda.

The EESC has also put mental health at the centre of its work. It has called for binding legislation to prevent psychosocial risks at work and is advocating for stepping up EU and national measures for promoting mental health.

By dedicating its 2023 prize to this all-important topic, the EESC wants to recognise the crucial role played by civil society in mental health treatment and prevention. Civil society fills gaps in the public health system, catering to the unique needs of vulnerable groups. Through its close connection with local communities, it provides frontline assistance both formally and informally, reaching populations that are often overlooked.

PREVIOUS CIVIL SOCIETY PRIZES

In 2022, the EESC exceptionally awarded a prize for two themes: youth and Ukraine. In 2021, the prize honoured climate projects promoting a just transition. In 2020, the EESC replaced its Civil Society Prize with a one-off Civil Solidarity Prize dedicated to the fight against COVID-19. Other topics in the past have included gender equality and women's empowerment, European identities and cultural heritage, and migration.

Civil society organisations, individuals and private companies can now apply their non-profit projects for the EESC Prize to support the mental well-being of Europeans.

The European Economic and Social Committee (EESC) launched the 14th edition of its Civil Society Prize. In order to reward creative and innovative non-profit projects that help people with mental illnesses and create an environment conducive to their mental well-being, either on an individual level or as part of a joint effort, the EESC has chosen mental health as this year’s theme.

A maximum of five winners will be selected to receive prizes of a total value of A total of EUR 50 000.

The closing date for applications is 30 September 2023, 10 a.m. (Brussels time).

The award ceremony is likely to take place during the EESC Civil Society Week in spring 2024.

The aim of the EESC's flagship Civil Society Prize is to raise awareness of civil society's outstanding contribution to creating a European identity and citizenship and to promoting the common values that bolster European integration. Each year, the prize focuses on a different theme particularly relevant to the EU.

 WHO CAN APPLY?

Applications can be submitted by all civil society organisations officially registered within the European Union and acting at local, regional, national or European level. The prize is also open to individuals who reside in the EU, as well as to companies registered or operating within the EU, provided that their projects are strictly not-for-profit.

All eligible initiatives and projects have to be carried out in the EU. They must have already been implemented or still be ongoing. Those which are planned but which have not begun implementation by 30 September 2023 will be excluded.

The full description of requirements and the online application form available on our webpage..

 WHICH PROJECT THEMES ARE ELIGIBLE?

To be eligible, the entries must cover at least one of the issues listed in the eligibility criteria published in the Rules governing the 14th EESC Civil Society Prizeavailable on the EESC's dedicated webpage. web page.

Among other things, projects can focus on preventing and combating psychosocial risks at work and promoting supportive workplace cultures, reaching out to people at risk of mental health problems, providing crisis intervention and ensuring person-centred services for mental health.

They can also address the mental health needs of disadvantaged groups and ageing populations or promote mental well-being in children and adolescents, by tackling issues such as substance use and abuse, cyberaddiction, youth violence and bullying.

Projects focused on community work such as empowering local communities, creating networks for community involvement and establishing a supportive environment for mental health will also be eligible. Improving mental health literacy and combating the stigma which often deters people from seeking help are also acceptable as entry themes.

The EESC hopes its prize will honour and showcase the non-state efforts made so far to help people battling with mental health issues. It also aims to encourage ongoing projects and inspire new ones, thus highlighting the contribution such projects can make to curbing the explosion of this silent epidemic in the EU.

 To apply, click  here..

 MORE ABOUT THE THEME OF THIS YEAR'S PRIZE

During and in the aftermath of the COVID-19 pandemic, Europe saw an unprecedented spike in mental health conditions and disorders. Anxiety and depression were particularly prevalent among the elderly and vulnerable groups, and most of all among young people, with figures showing that the rate of depressive symptoms more than doubled among those aged 18 to 29 in several European countries.

The heavy impact of mental health issues on the EU population, with roughly 4% of annual deaths attributed to mental health and behavioural disorders and the direct and indirect costs of mental health problems accounting for almost 4% of GDP, pushed mental health to the top of the EU's political agenda.

The EESC has also put mental health at the centre of its work. It has called for binding legislation to prevent psychosocial risks at work and is advocating for stepping up EU and national measures for promoting mental health.

By dedicating its 2023 prize to this all-important topic, the EESC wants to recognise the crucial role played by civil society in mental health treatment and prevention. Civil society fills gaps in the public health system, catering to the unique needs of vulnerable groups. Through its close connection with local communities, it provides frontline assistance both formally and informally, reaching populations that are often overlooked.

 

PREVIOUS CIVIL SOCIETY PRIZES

In 2022, the EESC exceptionally awarded a prize for two themes: youth and Ukraine. In 2021, the prize honoured climate projects promoting a just transition. In 2020, the EESC replaced its Civil Society Prize with a one-off Civil Solidarity Prize dedicated to the fight against COVID-19. Other topics in the past have included gender equality and women's empowerment, European identities and cultural heritage, and migration.

Contact for further information:

EESC Press Unit – Laura Lui
+ 32 (0)2 546 91 89

Europe Direct Karlovac and the Public Institution Regional Development Agency of Karlovac County in cooperation with numerous partners organised a series of events to mark the 10th anniversary of Croatia’s membership in the European Union and the 10th birthday of Europe Direct Karlovac. Europe Direct Karlovac started operating on 29 October 2013 as the first in Croatia and 500th in the European Union.

Here’s an overview of how we marked the big ten.

The celebrations started on 1st July and we joined the programme on the invitation of the organisers, the ‘ANNO’93’ association in Vienna, which brings together the Croatians there. The celebration of the 10 years of the Republic of Croatia in the European Union took place at the Yurovski Brod – Metlika border crossing point with two former Prime Ministers of the Republic of Croatia and the Republic of Slovenia, Jadranke Kosor and Borut Pahor.

On July 6th in cooperation with our long-standing partners, Kinoklub Karlovac and Carpe DiEM, we participated in the ArtiKA Good Amusement Festival, which included various workshops, IKS Petrinja’s ‘Budi cool – Volontiraj!“ children’s exhibition and the ‘Writers to the City’ of members of the Bookshop Karlovac. 18 teams took part in the KA quiz by Dražen Cukina, with questions about the city of Karlovac and the European Union, and we secured prizes for the first three places with Carpe DiEM. The quiz and the award ceremony to the winners were followed by a screening of the European film ‘Night Travellers’.

The ceremonial celebration of ten years of Croatian membership in the European Union and the tenth birthday of Europe Direct Karlovac was held in the Aquatika – Freshwater Aquarium Karlovac on 10 July. We have prepared the exhibition “10 projects of KŽ for 10 years of the Republic of Croatia in the EU”, where we presented 10 successfully implemented projects from the territory of Karlovac County financed by EU funds. The projects that were part of the exhibition are: Meeting with the river, Water secrets Slunja, Atrium of Knowledge, STREAM – Strategic Development of flood management, Nikola Tesla Entrepreneurial Center, Promoting sustainable development of the Significant Landscape of Barac Caves, Grain Trade Route/Wineway, Kupa-Sava, Visitor Center Ivana’s fairytale house, Sweetwater Aquarium and River Museum – Kaquarium, RCK – profession and RCK – career. With selected projects we wanted to remind our guests and fellow citizens of the importance and benefits of membership in the European Union. Also, in cooperation with the Embassy of the Republic of Ireland, we have set up an exhibition “50 Years of Ireland in the EU” in order to introduce our fellow citizens to the rich history of Ireland, which could be seen from 7-12 July at the Aquatika Green Library.

Marijana Tomičić and Eva Maria Sobotik Pavan told us about the very beginnings of Europe Direct, who brought him to Karlovac. About the present and the importance of Europe direct Karlovac for the future, as well as the benefits of membership in the European Union, their thoughts were conveyed to us by the Director of JURRA dr.sc. Vilko Klasan, Mayor of Karlovac Damir Mandić and Mayor of Karlovac County Martina Furdek Hajdin. After visiting the exhibition we continued to socialise with longtime partners and associates and representatives of local media. We would like to once again thank all our partners and look forward to future cooperation and to address the challenges ahead.

The great final of marking the great 10 years was the fabulous concert of Matija Cveka & The Funkensteins at the Music Pavilion as part of the "Zvjezdano ljeto" in Karlovac, which delighted many audiences. The concert was a gift to our fellow citizens and their guests, so we celebrated together our 10th and 444th birthday of Karlovac City.

The Ministry of Regional Development and EU Funds, in cooperation with the European Commission, organised in Zagreb from 5 to 7 June 2023 a meeting of the members of the INFORM EU network led by the European Commission and comprising communicators on EU funds from all EU Member States. The visit takes place each time in another Member State and this time Croatia was elected as host country, i.e. the city of Zagreb.

Visits to successful EU projects were organised as part of the event, with 100 INFORM EU members visiting Karlovac. As part of their visit to Karlovac, they visited Aquatic – the freshwater aquarium Karlovac, Nikola Tesla Experience Center and Meduza, Logo, as examples of successfully implemented EU-funded projects.

These projects were visited by Monika Hencsey, Director-General for Regional and Urban Development of the European Commission, followed by a visit to Europe Direct Karlovac, where she also met with local media.

„I am happy to be here today in Karlovac on behalf of the European Commission in a special year in which Croatia will celebrate 10 years of EU membership and where you joined the euro and the Schengen zone. I think that Croatia has proven its European heritage and how important it is for the European Union. Karlovac is the great place we are witnessing" said Hencsey to journalists..“, rekla je Hencsey novinarima .

It reiterated that Croatia has EUR 9 billion at its disposal in the new financial period until 2027, which will continue to invest in development with a greater focus on green energy, digital and on reducing the gap between poorer and richer regions, thus focusing on mountainous regions, but also on demography and creating conditions for increasing the population especially in rural areas.

She also put forward an interesting idea to further promote Karlovac in the European Union: “you would need to film Netflix’s Nikola Tesla film. Some of us did not know that he lived here and was trained. You have a great story to tell the EU. In addition, you have many rivers and clean and drinking water is very important. Today, we are struggling with a lack of energy, it is costly and scarce. I believe that in the future, water will be what is today’s energy. Managing your rivers in a clean and sustainable way is what will give you even more visibility in Europe. I really hope you will use more renewable, geothermal energy when I arrive next. These are long-term investments that the Cohesion Fund can finance" said Hencsey. „Trebali biste snimiti Netflixov film o Nikoli Tesli. Neki od nas nisu znali da je on ovdje živio i školovao se. Imate izvrsnu priču za ispričati u EU. Osim toga imate mnogo rijeka, a čista i pitka voda je vrlo važna. Danas se borimo s nedostatkom energije, skupa je i oskudna. Vjerujem da će u budućnosti voda biti ono što je današnja energija. Upravljanje vašim rijekama na čist i održiv način je ono što će vam dati još više vidljivosti u Europi. Stvarno se nadam i da ćete, kada dođem idući puta, koristiti više obnovljive, geotermalne energije. To su dugoročne investicije koje kohezijski fond može financirati“ rekla je Hencsey.

At the end of the visit, we walked through the Star so that our guests could see projects in implementation and where EU funds go.

Europe Direct Karlovac and the Public Institution Regional Development Agency of Karlovac County, in cooperation with numerous partners, organized a three-day celebration of Europe Day. The birthday of the European Union is celebrated every year on May 9. as a reminder to preserve lasting peace and unity, in memory of the historic "Schuman Declaration" from 1950. Europe Day 2023 is a sign of the European Year of Skills, in other words, focusing on lifelong learning and acquiring new skills, which was the main reason for organizing a series of lectures and workshops, as well as a quiz on knowledge of the European Union. We present an overview of how it all looked.

Three-day celebration, 09.05. we started in cooperation with our partner "Kinoklub Karlovac" with a screening of the Bulgarian film "Shelter", which was followed by an analysis of the film and a round table, and Boris Bakal gave a lecture on film art to students of the 3rd grade of Duga Resa High School, majoring in media technicians. CinEd was also presented - the European professional training program for teachers, professors, educators, pedagogues and interested professionals to teach children and young people about current issues that we encounter every day through film. As part of the project, the online platform https://www.cined.eu/collection is also active, which provides free access to a curated collection of top European heritage and contemporary art films with Croatian subtitles.

After that, in cooperation with the City Library "Ivan Goran Kovačić" Karlovac, in the Department for Children and Youth, students of the 4th grade of Grabrik Elementary School participated in a workshop called "Awareness and training of life and social skills through play" led by librarian Gabrijela Vine . The inspiration for conducting the workshop came from the books "Exercising Life Skills" by Jelena Bićanić and "Children's Games for the Development of Social Skills" by Deborah M. Plummer. Through the games Send it on!, Five and Joker, Pyramid of Life and Fear of School, we practiced the skills of cooperation, careful observation, memory, concentration, non-verbal communication, overcoming fear, empowerment and many others. In order to successfully advance in the education system, and later compete in the labor market, it is desirable to acquire good and sovereign mastery of both life and social skills from an early age, and these students experienced all this through play, the simplest way of learning.

On Wednesday 10.05. the central event marking Europe Day was organized in the newly opened Nikola Tesla Experience Center, where we hosted students from the Polytechnic in Karlovac and high school students from the Karlovac Gymnasium and the Karlovac Economic and Tourism School. Why them? It is precisely because high school students and students are the group that will soon enter the labor market that is why a lecture on lifelong learning and the presentation of vouchers was held in front of the Croatian Employment Service, Regional Office Karlovac.

With the education entitled "AI panic? - let's talk about artificial intelligence", Kinoklub representatives: Ksenija Sanković and Lucija Ćeškić continued to promote media literacy, given that it deals with content creation and technical conditions, as well as critical thinking, and artificial intelligence is currently a very popular topic. Within the topic of artificial intelligence, the results of the evaluation of workshops on media literacy of young people prepared and processed by prof. Martina Vičić Crnković from Karlovac Gymnasium.

The quiz "How well do I know Europe" was prepared by prof. Margareta Kulaš from Karlovac Gymnasium, which took place online via the Kahoot platform, and the three most successful couples also won prizes.

After the quiz on knowledge of the European Union, a guided tour through the interpretation center dedicated to Nikola Tesla was organized for all participants.

On Thursday, 11.05. in the "Ivan Goran Kovačić" City Library, we finished celebrating Europe Day with an educational workshop for preschool children called "EU and I". By recognizing the flags and coloring them, the children learned what the European Union is, how many members it has, how many years the Republic of Croatia has been a member, what other countries are in the EU, and what each country is known for.

We can conclude that with this three-day celebration of Europe Day, we put skills in the spotlight, because investing in education and training is crucial for the future of every individual. The European Year of Skills will be a new impetus in achieving the social goals of the EU by 2030, according to which at least 60% of adults should be trained every year, and at least 78% should be employed.

#DanEurope #EuropeDay #EuropanYearOffSkills

Komisija predlaže reviziju zakonodavstva EU-a o lijekovima kako bi ono postalo fleksibilnije i prilagođenije potrebama građana i poduzeća u cijeloj Uniji. Riječ je o najvećoj reformi u posljednjih 20 godina i više. Revizijom će se omogućiti veća dostupnost, pristup i cjenovna pristupačnost lijekova. Podupirat će se inovacije i poticati konkurentnost i privlačnost farmaceutske industrije EU-a te pritom promicati viši okolišni standardi. Uz tu reformu Komisija predlaže Preporuku Vijeća za jačanje borbe protiv antimikrobne otpornosti.

Reformom se svladavaju bitni izazovi. Lijekovi odobreni u EU-u još uvijek ne stižu dovoljno brzo do pacijenata niti su jednako dostupni u svim državama članicama. Postoje znatni nedostaci kad je riječ o nezadovoljenim medicinskim potrebama, rijetkim bolestima i antimikrobnoj otpornosti. Visoke cijene inovativnih načina liječenja i nestašice lijekova i dalje su velik problem za pacijente i zdravstvene sustave. Osim toga, kako bi osigurao da ostane privlačno mjesto za ulaganja i svjetski predvodnik u razvoju lijekova, EU treba prilagoditi svoja pravila digitalnoj transformaciji and novim tehnologijama te smanjiti birokraciju i pojednostavniti postupke. Naposljetku, novim pravilima treba se riješiti problem utjecaja proizvodnje lijekova na okoliš u skladu s ciljevima europskog zelenog plana.

Revizija uključuje prijedloge nove direktive i nove uredbe kojima se revidira i zamjenjuje postojeće zakonodavstvo o lijekovima, uključujući zakonodavstvo o lijekovima za djecu i za rijetke bolesti. Nastoje se postići sljedeći glavni ciljevi:

·         stvaranje jedinstvenog tržišta za lijekove kako bi svi pacijenti u EU-u imali pravodoban i pravedan pristup sigurnim, učinkovitim i cjenovno pristupačnim lijekovima

·         osiguravanje atraktivnog okvira za istraživanja, razvoj i proizvodnju lijekova u Europi kojim se potiču inovacije

·         drastično smanjenje administrativnog opterećenja ubrzavanjem postupaka kako bi se znatno smanjilo vrijeme potrebno za izdavanje odobrenja za lijekove i lijekovi bili brže dostupni pacijentima

·         povećanje dostupnosti i osiguravanje da se lijekovi pacijentima mogu isporučiti u svakom trenutku, bez obzira na to gdje u EU-u žive

·         borba protiv antimikrobne otpornosti i prisutnosti lijekova u okolišu, putem pristupa „jedno zdravlje”

·         povećanje okolišne održivosti lijekova.

Kako bi se ti ciljevi ostvarili, reforma se odnosi na cijeli životni ciklus lijekova.

Ključni elementi prijedloga:

·         Bolji pristup pacijenata i nacionalnih zdravstvenih sustava inovativnim i cjenovno pristupačnim lijekovima: Novim poticajima poduzeća će se poticati da svoje lijekove stave na raspolaganje pacijentima u svim zemljama EU-a i da razviju proizvode kojima se ispunjavaju nezadovoljene medicinske potrebe. Nadalje, omogućit će se ranija dostupnost generičkih i biosličnih lijekova te pojednostavniti postupci izdavanja odobrenja za stavljanje u promet. Uvest će se mjere za povećanje transparentnosti javnog financiranja razvoja lijekova i poticati izrada usporednih kliničkih podataka.

·         Promicanje inovacija i konkurentnosti učinkovitim i pojednostavnjenim regulatornim okvirom: Reformom će se stvoriti na inovacije usmjereno regulatorno okruženje za razvoj novih lijekova i prenamjenu postojećih. Europska agencija za lijekove (EMA) pružat će bolju ranu regulatornu i znanstvenu potporu subjektima koji razvijaju obećavajuće lijekove kako bi se omogućilo brzo odobravanje i pomoglo MSP-ovima i neprofitnim subjektima koji razvijaju lijekove. Ubrzat će se znanstvena ocjena i odobravanje lijekova (npr. EMA-ini postupci odobravanja trajat će 180 dana, čime će se doprinijeti smanjenju sadašnjeg prosjeka od oko 400 dana), a regulatorno opterećenje smanjit će se pojednostavnjenjem postupaka (npr. ukidanjem zahtjeva za produljenje odobrenja za stavljanje u promet u većini slučajeva te uvođenjem jednostavnijih postupaka za generičke lijekove) i digitalizacijom (npr. elektroničko podnošenje zahtjeva i elektroničke informacije o proizvodima). Zadržat će se najviši standardi kvalitete, sigurnosti i učinkovitosti za odobravanje lijekova.

·         Djelotvorni poticaji za inovacije: Regulatornom zaštitom u trajanju do najviše 12 godina za inovativne lijekove, u kombinaciji s postojećim pravima intelektualnog vlasništva, osigurat će se da Europa ostane privlačno mjesto za ulaganja i inovacije. Radi stvaranja jedinstvenog tržišta lijekova reformom će se postojeći sustav preusmjeriti s univerzalne regulatorne zaštite na djelotvorniji okvir poticaja za inovacije kojima se promiču i interesi javnog zdravlja. Kako bi se to postiglo, predlaže se minimalno razdoblje regulatorne zaštite od 8 godina koje se može produljiti u sljedećim slučajevima: ako se lijekovi stavljaju u promet u svim državama članicama, ako se njima odgovara na nezadovoljene medicinske potrebe, ako se provode usporedna klinička ispitivanja ili ako se razvije nova terapijska indikacija. Kombinacijom postojećih prava intelektualnog vlasništva i novih razdoblja regulatorne zaštite zaštitit će se i konkurentska prednost koju EU uživa zahvaljujući jednoj od najviših razina zaštite na svijetu kad je riječ o razvoju lijekova. Reformom će se poticati usmjeravanje istraživanja i razvoja na najveće potrebe pacijenata te pravodobniji i pravedniji pristup pacijenata lijekovima u cijeloj Uniji.

·         Rješavanje problema nestašica lijekova i osiguravanje sigurnosti opskrbe: Reformom se uvode novi zahtjevi za praćenje nestašica lijekova koje provode nacionalna tijela i EMA te jača koordinacijska uloga EMA-e. Povećat će se obveze poduzeća, što uključuje ranije izvješćivanje o nestašicama lijekova i povlačenju lijekova s tržišta te izradu i upravljanje planovima za sprečavanje nestašice. Sastavit će se popis ključnih lijekova na razini EU-a i procjenjivati slabosti lanca opskrbe tim lijekovima te pritom dati posebne preporuke o mjerama koje poduzeća i drugi dionici u lancu opskrbe trebaju poduzeti. Komisija može donijeti i pravno obvezujuće mjere radi jačanja sigurnosti opskrbe određenim ključnim lijekovima.

·         Bolja zaštita okoliša: Boljom provedbom postojećih okolišnih zahtjeva ograničit će se mogući negativni utjecaj lijekova na okoliš i javno zdravlje.

·         Suzbijanje antimikrobne otpornosti: Antimikrobna otpornost smatra se jednom od tri najveće prijetnje zdravlju u Uniji. Reformom se pružaju poticaji u obliku prenosivih vaučera poduzećima koja ulažu u nove antimikrobike koji mogu liječiti otporne patogene, čime se odgovara na problem tržišnog neuspjeha. Radi očuvanja učinkovitosti antimikrobika uvest će se i mjere i ciljevi za njihovu razboritu uporabu, uključujući prilagođeno pakiranje i obvezno izdavanje na recept.

Jačanje djelovanja EU-a za borbu protiv antimikrobne otpornosti primjenom pristupa „jedno zdravlje”

Antimikrobici su lijekovi od ključne važnosti. Međutim, zbog njihove prekomjerne i pogrešne uporabe tijekom godina povećala se antimikrobna otpornost, što znači da antimikrobici gube svoju učinkovitost, zbog čega je sve teže ili nemoguće liječiti infekcije. Stoga današnji paket uključuje i Prijedlog preporuke Vijeća koji sadržava dopunske mjere za borbu protiv antimikrobne otpornosti u području zdravlja ljudi, zdravlja životinja i okoliša u okviru takozvanog pristupa „jedno zdravlje”.

Prijedlogom se podupire razborita uporaba antimikrobika, preporučuju konkretni i mjerljivi ciljevi za smanjenje njihove uporabe i promiče visoka razina sprečavanja (posebno u bolnicama) i kontrole infekcija kod ljudi. Prijedlogom se poboljšava i informiranost javnosti, obrazovanje i osposobljavanje relevantnih djelatnika te potiče suradnja među dionicima iz svih relevantnih sektora.

Preporučeni ciljevi osmišljeni su uz potporu Europskog centra za sprečavanje i kontrolu bolesti (ECDC) uzimajući u obzir situaciju u pojedinim zemljama (razlike u razinama potrošnje antimikrobika i raširenosti ključnih otpornih patogena u državama članicama). Njima će se omogućiti i bolje praćenje napretka u narednim godinama.

Osim toga, Prijedlogom će se ojačati nacionalni akcijski planovi protiv antimikrobne otpornosti u okviru pristupa „jedno zdravlje”, poticati istraživanja i inovacije, pojačati nadzor i praćenje antimikrobne otpornosti i potrošnje antimikrobika, ojačati globalno djelovanje, pridonijeti osmišljavanju EU-ovih višedržavnih financijskih poticaja za poboljšanje pristupa antimikrobicima i potaknuti razvoj drugih medicinskih protumjera za borbu protiv antimikrobne otpornosti, kao što su cjepiva i brza dijagnostika.

Context

Komisija je u studenome 2020. predstavila farmaceutsku strategiju za Europu, kojom se nastoji stvoriti farmaceutsko okruženje koje će biti otporno na buduće promjene i usmjereno na pacijente i u kojem industrija EU-a može inovirati, razvijati se i zadržati svoju poziciju globalnog predvodnika.

Farmaceutski ekosustav EU-a koji je otporan na krize, prilagođen današnjici i pripremljen na buduće izazove jedan je od središnjih stupova snažne europske zdravstvene unije i dopunjavat će druge važne inicijative, kao što su jačanje okvira EU-a za zdravstvenu sigurnost novim zakonodavstvom o prekograničnim prijetnjama zdravlju i većim ovlastima za zdravstvene agencije EU-a te uspostava Tijela za pripravnost i odgovor na zdravstvene krize (HERA), europskog plana za borbu protiv raka i europskog prostora za zdravstvene podatke.

Strategijom je pokrenuta ambiciozna revizija postojećeg zakonodavstva o lijekovima, što predstavlja sveobuhvatan odgovor na trenutačne izazove s kojima se suočava farmaceutski sektor Unije.

Više informacija može se pronaći na slijedećim poveznicama:

Pitanja i odgovori o zakonodavstvu o lijekovima

Pitanja i odgovori o Preporuci o antimikrobnoj otpornosti

Informativni članak o stavljanju pacijenata u središte

Informativni članak o poticanju inovacija u farmaceutskoj industriji

                                                           Informativni članak o suzbijanju antimikrobne otpornosti

                                                           Farmaceutska strategija za Europu

                                                          Djelovanje EU-a u području antimikrobne otpornosti

                                                           Videozapis o reviziji zakonodavstva o lijekovima